| ICH Guideline Videos by year |
| ICH |
Programs |
Speakers |
Video |
Materials |
| KOR |
ENG |
Files |
| ICH |
| ICH |
ICH Cooperation activity and implementation status of ICH guidelines in Korea |
Heesung Kim
(NIFDS, MFDS)
|
|
|
|
| Quality |
| Q3C(R9) |
Risk-Based Approach for Evaluation and Control Strategy of Residual Solvents in Pharmaceuticals |
Ji Sun Yoo
(Daewoong Pharm)
|
|
|
|
| Q3D(R2) |
Elemental Impurity Risk Assessment |
Andrew Teasdale
(ATCMC Solutions Limited)
|
|
|
|
| Q9(R1) |
Integration of QRM in Quality Management Systems
-Quality Management System Applications of Risk-Based
Decision-Making Approaches
|
Marion de la Cruz-Kuo
(MSD)
|
|
|
|
| Q2(R2)/Q14 |
Analytical Procedure Development and Change Management Concepts in ICH Q14 |
Nina Cauchon
(Amgen)
|
|
|
|
| Q2(R2)/Q14 |
ICH Q2(R2)/Q14 Training based on Training Materials |
Yukio Hiyama
(National Institute of Health Sciences)
|
|
|
|
| Q3E EWG |
ICH Q3E: Guideline for Extractable and Leachables |
Patricia Parris
(Pfizer)
|
|
|
|
| Multidisciplinary |
| M7(R2) |
M7(R2): N-Nitrosamines
-Past, Present and Future
|
Andrew Teasdale
(ATCMC Solutions Limited)
|
|
|
|
| M7(R2) |
ICH M7(R2) - Risk-Based Assessment and Control Strategies for Genotoxic Impurities Using Real-World Case Studies (Including Manufacturing Processes)
|
Kazusei Komatsu
(Shionogi)
|
|
|
|
| M4Q(R2) EWG |
ICH M4Q(R2) and the Way Forward
|
Lawrence Yu
(FDA)
|
|
|
|
| M14 EWG |
Introduction to the ICH M14 Guideline (Step 3)
|
Bongkyoo Choi
(GC Biopharma)
|
|
|
|
| M15 EWG |
Envisioning Global Harmonization of MIDD: Opportunities and Challenges in the Implementation of the New ICH M15 MIDD Guidelines
|
Jiawei Wei
(Novartis)
Daisuke Iwata
(PMDA)
|
|
|
|
| Efficacy |
| E2C(R2) |
Mastering PBRER Preparation: Best Practices and Global Regulatory Insights
|
Minkyung Shin
(Selta Square)
|
|
|
|
| E6(R3) |
ICH E6(R3) – The implementation
|
Rebecca Stanbrook
(Novartis Pharma AG)
|
|
|
|
| E14/S7B |
Best practice condideration for the in vitro cardiac ion channel and in vivo QT studies (S7B Q&A, Best practice)
|
Joung-Wook Seo
(Korea Institute of Toxicololgy)
|
|
|
|
| Safety |
| S2(R1) |
Interpretation of S2(R1) Genotoxicity Data, Decision Criteria, and Regulatory Response Cases |
Hyun-Kul Lee
(Corestemchemon)
|
|
|
|
| S10 |
Photosafety Evaluation of Pharmaceuticals since Implementation of ICH S10 |
Daniel Bauer
(Novartis Pharma AG)
|
|
|
|
